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Regulatory Affairs & Quality Assurance Associate Manager
Are you passionate about making sure every detail has been met? Do you love crafting business strategies?
All of our roles provide competitive wages as well as the opportunity to engage and grow in your profession across growing categories. At this job, you will help deliver our brands advance to market and will support procedures to ensure the compliance of all product and retail packages.
As a Regulatory Affairs Associate Manager, you will be responsible for:
- Independently performing regulatory activities to support successful local approvals of new Marketing authorization and maintaining Marketing Authorizations including renewal, variations during the lifecycle of assigned products.
- Give strategic inputs into projects to meet business objectives
- For projects assigned, in charge of the development of sound regulatory strategies and properly execute them while elaborating risk mitigation plans that support the company's portfolio
- Act as functional expert on local/regional/global project teams for projects, interpreting issues and provide strategic input to project team on the application of local regulations, review processes and submission requirements
- Develop and manage optimal labelling for all products throughout the product lifecycle in close alignment global labelling group and meeting corporate labelling standards
- Monitor regulatory environment, assess impact on assigned portfolio and timely communicate to internal stakeholders. Works on mitigation plan to optimize submission strategies and maximize business benefit.
- Establish and maintain excellent working relationships with review staff of local relevant authority where applicable, and other local regulatory agencies, as required.
- Keeps close contact with the affiliates/local regulatory partners for exchange of regulatory requests and information regarding the allocated tasks
You will report to the Head of Regulatory Affairs ASEAN (RA) and QA Head of Operations (QA).
What success looks like
- Ensure no critical finding for audits
- Ensure regulatory and quality compliance is upheld
- Act as a valuable business partner to all functions to support in ensuring business deliverables are met
- Ensure seamless integration of products and business setup
What we offer you
- Responsibilities from Day 1 – You will start working for key categories or brands from the beginning. Over time, as you expand your impact on the business, your responsibility and ownership of a brand will quickly grow.
- Recognized state of the Research & Development skills – We will constantly help you improve your research knowledge and management abilities.
- You'll receive continuous coaching & mentorship– We are passionate about our work. We will make sure you receive both formal training and as regular mentorship from your manager and others.
- You'll be part of a dynamic and respectful work environment – We live our Purpose, Values, and Principles daily. We value every individual and encourage initiatives promoting agility and work/life balance.
- You'll join an international team with regional responsibilities.
- Flexible work arrangements.
- Competitive salary and benefits program
- Regular salary revisions and possible promotions - all in line with your results, performance and potential.
- Qualified Pharmacist by education with a bachelor’s degree in pharmacy
- Working experience of min 5 years in the field of regulatory affairs
- Demonstrated managerial skills, specially having a strong track record of success as a leader or agent of change and ability to lead multiple projects
- Able to work independently, multi-task, and perform in a high-pressure meaningful environment.
- Have excellent problem-solving skills and uses data to connect multiple ideas and develop solutions
- Have strong interpersonal skills and good partnership to collaborate with people from diverse cultures and levels, both internally and externally
- Utilize critical thinking to lead, formulate, propose and execute RA plans and strategies for the various technical and analytical regulatory assignments
- Fluent in English and Vietnamese (in reading, writing and interpersonal skills)
- Familiar/experienced with Vietnam Good Storage and Distribution Practices
- Familiar with ASEAN, WHO and national guidelines for pharmaceutical industry
We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, Tampax® and more. Our community includes operations in approximately 70 countries worldwide.
Visit http://www.pg.com to know more.
Our consumers are diverse and our talents - internally - mirror this diversity to best serve it. That is why we’re committed to building a winning culture based on Inclusion and our ideal candidate is passionate about the same principle: you will join our daily effort of being “in touch” so we craft brands and products to improve the lives of the world’s consumers now and in the future. We want you to inspire us with your unrivaled ideas.
We are committed to providing equal opportunities in employment. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, veteran status, HIV/AIDS status, or any other legally protected factor.
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